Quality Systems Specialist

About 20BLOC

Located in Thousand Oaks, California, 20BLOC is a small privately held development-stage biopharmaceutical company, driven by a mission to create breakthrough protein-based drugs to save lives. Our lead product is an innovative solution to provide oxygen to tissues. Check us out at www.20bloc.com _._

We are looking for a motivated and hands-on Quality Systems Specialist to join our team.

How you will add value to 20BLOC

The Quality Systems Specialist supports the Quality Assurance function by ensuring compliance with Good Manufacturing Practice (GMP) requirements. This role is responsible for development and support of the Quality Management System (QMS), including Supplier Qualification and oversight of quality Events and Change Control. The Quality Systems Specialist works closely with Manufacturing, QC, Supply Chain and other cross-functional teams to ensure product quality, data integrity, and regulatory compliance.

Key Responsibilities

Supplier Quality

• Supplier risk assessment and classification
• Oversight of supplier audits (on-site and paper audits)
• Management of Supplier Agreements

Quality Systems

• Development and oversight of electronic Quality Management Systems (e-QMS)
• Development of the Deviation and CAPA Quality System, supporting investigations, including root cause analysis and CAPA planning, and quality approval of deviations
• Development of the Change Control Quality System, including impact assessments and Quality approval
• Oversight of the document control and GMP training Quality Systems
• Ensure documentation practices comply with data integrity and GMP requirements

Compliance & Continuous Improvement

• Support internal audits and regulatory inspections, including preparation of documentation and responses
• Assist in tracking and trending quality events and quality metrics
• Support risk assessments and continuous improvement initiatives
• Ensure timely closure of deviations, CAPAs, and change controls

Cross-Functional Support

• Collaborate with Manufacturing, QC, and other departments to resolve quality issues
• Provide GMP guidance and support to operational teams
• Participate in training activities related to GMP and quality procedures

Education

• Bachelor’s degree in Life Sciences or a related field

Experience

• 4 years+ of experience in Quality Assurance within a GMP-regulated pharmaceutical environment
• Experience in Supplier Quality management
• Experience with e-QMS
• Experience managing deviations, change control, training, and document control
• Working knowledge of regulatory requirements (e.g., FDA, EMA, ICH guidelines)

Skills & Competencies

• Strong understanding of GMP and pharmaceutical quality systems
• High attention to detail and strong documentation skills
• Ability to investigate issues and perform root cause analysis
• Strong organizational and time management skills
• Effective written and verbal communication skills
• Ability to work independently and collaboratively in a team environment
• Proficiency with electronic QMS systems

Please apply at _jobs@20bloc.com_ – in subject line: Quality Systems Specialist

This is a full-time, on-site position located in Thousand Oaks, California, and requires working on-site Monday through Friday.All applicants must be authorized to work in the United States. We are not sponsoring employment visas.

_Compensation: The salary range for this position is_ _$82,000.00. to $109,00.00 USD_ _annually. This salary range is an estimate, and the actual salary may vary based on various factors, including, without limitation, individual education, experience, tenure, skills, and abilities, as well as internal equity and alignment with market data, including potential adjustments for geographic location._

_20BLOC is an equal opportunity employer. All applicants will be considered for employment without attention to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran or disability status, or other applicable legally protected characteristics._

_We offer competitive compensation and benefits including health, dental, vision and life insurance, 401(k) and paid time off._